14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
NATUS MEDICAL
FDA UDI
NATUS MEDICAL INCORPORATED·00382830044028·ALGO 3i Preamplifier, Short Length
Algo 3i
FDA UDI
Natus Medical Denmark ApS·05713315012211·Preamp cable with EEG lead cable (short)
ENVAN HEART RATE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
EMBRYON GIFT TRANSFER CATHETERS/SETS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TENDRIL STS
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·March 26, 2024
CADD
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·March 23, 2022
CADD MEDICATION CASSETTE
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·July 14, 2022
CADD
FDA Adverse Event
Malfunction
·NULL·Product code FPA·August 17, 2021
CADD MEDICATION CASSETTES
FDA Adverse Event
Malfunction
·ST PAUL·Product code FPA·June 6, 2022
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·April 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 22, 2011
AISYS
FDA Adverse Event
Other
·DATEX-OHMEDA·Product code BSZ·May 6, 2008
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018